M6620, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Head and Neck Carcinoma of Unknown Primary
- Head and Neck Squamous Cell Carcinoma
- Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7
- Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7
- Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage III Sinonasal Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IV Sinonasal Squamous Cell Carcinoma AJCC v7
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of M6620 (VX-970) when administered along with weekly cisplatin and radiation therapy (XRT) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC). II. Establish the recommended phase 2 dose (RP2D) of the combi...
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of M6620 (VX-970) when administered along with weekly cisplatin and radiation therapy (XRT) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC). II. Establish the recommended phase 2 dose (RP2D) of the combination. SECONDARY OBJECTIVES: I. Characterize the pharmacokinetic (PK) profile of M6620 (VX-970). II. Assess for potential drug-drug interaction between M6620 (VX-970) and aprepitant. III. To observe and record anti-tumor activity. IV. To assess the rate of complete metabolic response (CMR) at 12 weeks post completion of chemoradiation using 18 fluorodeoxyglucose (FDG) positron emission tomography (PET) scans. V. To collect archival tumor material for retrospective analysis of association between tissue-based biomarkers and clinical outcome. OUTLINE: This is a dose-escalation study of ATR kinase inhibitor M6620. Patients receive berzosertib intravenously (IV) over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, every 2 weeks for 3 months, and then every 3 months for 2 years.
Tracking Information
- NCT #
- NCT02567422
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Taofeek K Owonikoko JHU Sidney Kimmel Comprehensive Cancer Center LAO